Therapeutical efficacy of immunobiotics in patients with newly diagnosed rheumatoid arthritis

Abstract

Introduction: Rheumatoid arthritis (RA) remission remains a key treatment goal, but remission rates vary. Emerging evidence suggests that gut microbiota modulation via probiotics may influence systemic inflammation and improve outcomes in RA. The objective was to evaluate the effects of adjunctive probiotic supplementation on clinical outcomes in patients with newly diagnosed RA receiving conventional disease-modifying antirheumatic drugs (cDMARDs) over 12 months.

Methodology: In this randomized, placebo-controlled trial, 100 patients with newly diagnosed RA were assigned to receive either probiotics containing Lactobacillus casei BLn2401, Lactobacillus salivarius BL2201, and Bifidobacterium breve BL3406 plus cDMARDs (experimental group); or cDMARDs alone (control). Clinical outcomes including disease activity score using 28 joints (DAS28), inflammatory markers (C-reactive protein, CRP; erythrocyte sedimentation rate, ESR), pain (visual analogue scale, VAS), functional disability (health assessment questionnaire, HAQ), and RA quality of life (RAQoL) questionnaire were assessed at baseline and follow-up. Remission rates and corticosteroid use were evaluated.

Results: The probiotic group demonstrated faster and more sustained reductions in DAS28, CRP, ESR, pain, and disability scores; compared to controls. The probiotic group achieved near-remission (DAS28 2.3 ± 0.4) by 12 months, while the control group reverted to baseline disease activity. Probiotic use was the independent predictor of remission or low disease activity (HR = 2.703, p < 0.001). Patient-reported quality of life improved significantly, and corticosteroid dependence decreased in the probiotic group.

Conclusions: Adjunctive probiotic supplementation with specific strains may enhance clinical outcomes, reduce inflammation, and increase remission rates in early RA, supporting probiotics as a safe, accessible adjunctive therapy.